“Various industry stakeholders have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act are unconstitutional. The impact of these judicial challenges as well as future actions and agency rules implemented by the government on us and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures, including the prescription drug provisions under the Inflation Reduction Act, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved. Complying with any new legislation and regulatory changes could be time-intensive and expensive, resulting in a material adverse effect on our business.”
All entries for: Therapeutics
Zymeworks
Negative Outlook
Middletown, DE
201-500 employees
Horizon Therapeutics
Negative Outlook
Deerfield, IL
1,001-5,000 employees
During HZNP’s earnings call, Madhu Kumar of Goldman Sachs inquired whether the Inflation Reduction Act’s drug pricing provisions have altered corporate strategy regarding indication expansions on approved drugs and pipeline candidates.
Zymeworks
Negative Outlook
Middletown, DE
201-500 employees
Zymeworks
Negative Outlook
Middletown, DE
201-500 employees
Zymeworks
Negative Outlook
Middletown, DE
201-500 employees
Concerns over Revenue Generation: “The implementation of cost containment measures, including the prescription drug provisions under the Inflation Reduction Act, as well as other healthcarereforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved”
Revance Therapeutics
Negative Outlook
Nashville, TN
501-1,000 employees
Impact to DAXXIFY: “ It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry… Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of, or affect the price that we may charge for, DAXXIFY™, or any future product candidates including an onabotulinumtoxinA biosimilar”
Horizon Therapeutics
Negative Outlook
Deerfield, IL
1,001-5,000 employees
• Income Taxes: “Pending further guidance, it is possible that the IRA could increase our tax liability, which could in turn adversely impact our business and future profitability. The IRA or future changes in U.S. tax laws could have a material adverse impact on the value of our deferred tax assets and liabilities, could result in significant one-time charges, and could increase our future U.S. tax expense.” • General Impact: “The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. It is currently unclear how the IRA will be effectuated but it is likely to have a significant negative impact on the pharmaceutical industry”
